Recruiting

CBT & IPT

Sponsor:

Hackensack Meridian Health

Code:

NCT06991166

Conditions

Post Partum Depression

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cognitive behavioral therapy (CBT) psychotherapy group/telehealth

Interpersonal therapy (IPT) psychotherapy group/telehealth

Study Details

Brief summary:

Postpartum Depression (PPD) is defined as depression that occurs after childbirth, with intense symptoms that last longer than "baby blues". PPD differs greatly from "baby blues", a term used to describe the typical sadness, worry and tiredness that women experience after childbirth, which often resolves within a week or two on its own. The symptoms of PPD interfere with many aspects of daily living and can have unhealthy short-term and long-term outcomes, both for the mother and baby.

One-third of women in the U.S. with PPD are identified in clinical settings, yet only half of those begin psychotherapy treatment. Unfortunately, mothers whose newborns are in the Neonatal Intensive Care Unit (NICU) are at high risk for developing PPD, necessitating early identification and evidence-based treatment. Cognitive behavioral therapy (CBT) and interpersonal therapy (IPT) are the two most effective psychotherapy treatments for PPD, yet no randomized controlled clinical trials were found that directly compared the two types of treatment or determined whether combining the two approaches is more helpful for PPD than either approach alone.

This clinical trial aims to compare the effectiveness of a 4-week intervention of either CBT or IPT for PPD in NICU mothers and to determine whether a sequential 8-week intervention (IPT then CBT, or CBT then IPT) is more beneficial.

Conditions

Post Partum Depression

Study ID

NCT06991166

Start date

Sep 15, 2025

Status verified date

Sep, 2026

Completion date

Sep 1, 2028

Anticipated

Primary completion date

Sep 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Mother of NICU infant
  • Older than age 18
  • English-speaking
  • Gave birth more than 24 hours ago and less than 12 months prior to enrollment
  • Depression as assessed by:

Current/Prior diagnosis of Major Depressive Disorder OR EPDS score above 10 OR EPDS score below 10 AND Endorsement of "sometimes" or "often" on item #10 on the EPDS\* ("I have had thoughts of harming myself")

Exclusion Criteria:

  • A diagnosis of Substance Dependency or Substance Use
  • Acute suicidal or infanticidal ideation
  • Current psychosis
  • Medical history of cognitive impairment
  • Infant death of current NICU admission
  • Marked non-compliance with intervention (e.g, non-attendance of more than one session during a 4-week intervention or failure to complete study assessments),
  • Are in medical treatment that would prevent participation (i.e., medical treatment that requires inpatient hospitalization and thus would prevent participation of study visits.)

Study Design

Enrollment

72 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 4-week Cognitive behavioral therapy (CBT) psychotherapy group/telehealth intervention

After the first 4-week of CBT intervention , participants will be administered the Peri-Intervention (Week 4) Assessment - which consists of the EPDS, Social Determinants of Health, and the Risk Factor questionnaire - and then "cross-over" to the second 4-week of IPT intervention.

experimental: 4-week interpersonal therapy (IPT) psychotherapy group/telehealth intervention

After the first 4-week of IPT intervention , participants will be administered the Peri-Intervention (Week 4) Assessment - which consists of the EPDS, Social Determinants of Health, and the Risk Factor questionnaire - and then "cross-over" to the second 4-week of CBT intervention.

Interventions

Cognitive behavioral therapy (CBT) psychotherapy group/telehealth

Type of psychotherapy. CBT focuses on identifying and changing unhelpful beliefs and behavioral patterns that lead to negative emotions (e.g., depression, anxiety, grief, shame) in order to break the emotion-thought-behavior cycle

Interpersonal therapy (IPT) psychotherapy group/telehealth

Type of psychotherapy. IPT focuses on improving interpersonal communication and deficits, processing grief, and role transitions

Primary outcome measure

  • Post Partum Depression post initial psychotherapy [ Time Frame: At 4 weeks ]

Central Contacts and Locations

Central contacts

Locations

Hackensack University Medical Center

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

More Information

Sponsor

Hackensack Meridian Health

Last update posted

Sep 8, 2026

Last verified

Sep, 2026

Keywords

  • Post Partum Depression
  • Cognitive behavioral therapy
  • interpersonal therapy
  • psychotherapy
  • NICU

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hackensack Meridian Health on 2026-09-08.